Optimizing Management and Medication of Febrile Children in Out-of-hours Primary Care: CHILI Cluster RCT (CHILI)
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| ClinicalTrials.gov Identifier: NCT02594553 |
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Recruitment Status :
Completed
First Posted : November 3, 2015
Last Update Posted : September 16, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Antibiotic Prescriptions Infection | Behavioral: GP-parent information-exchange tool | Not Applicable |
A GP-parent information exchange tool in the form of an interactive booklet has the potential to provide parents with information about symptoms and fever management and consistent information during GP consultations. Thereby enhancing their self-management and providing them with safety net advice when they return home.
It is hypothesized that the use of such an interactive booklet during consultations for febrile children at GP out-of-hours centres will result in a reduced number of antibiotic prescriptions, improved parental satisfaction and reduced intention to re-consult.
The development of the interactive booklet concerned a three-stage process and is based on extensive qualitative work among parents, GPs and other professionals involved in childhood fever management. The booklet incorporates already existing information about fever, alarm symptoms, advice on use of medication and specific infectious diseases that frequently occur in childhood in combination with fever such as upper respiratory tract infections, and otitis media.
We will perform a cluster-randomised controlled trial at 20 GP out-of-hours centres in the Netherlands. GP out-of-hours centres will be stratified by size, to ensure equal distribution of size between the intervention and control group. The required number of clusters and participants was based on the following assumptions: (1) ICC of 0.01, (2) alpha of 0.05, power of 0.80, (3) proportion of antibiotic prescriptions in control group of 25% and a proportion of 19% in the intervention group (6% minimal clinical relevant difference) and (4) 10% loss to follow-up and 10% efficiency loss based on unequal cluster sizes. Based on a previous cohort study, we estimated to include 1000 children per cluster (GP out-of-hours centre) within six months, resulting in a need for 20 clusters and an effective sample size of 737 patients in the intervention and control group (1474 in total).
The booklet will be used during consultations with febrile children at the GP out-of-hours centres that are randomly allocated by computer to the intervention. The child's symptoms will determine which information and advice parents receive from the GP.
Statistical analysis will be performed based on intention to treat principle by performing multilevel logistic regression analysis using IBM SPSS version 21.0 and MLwiN software. We will determine independent factors associated with antibiotic prescriptions. The same will be done for secondary outcomes.
All data will be obtained, managed and monitored according to the guidelines of Good Clinical Practice.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1262 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Optimizing Management and Medication of Febrile Children in Out-of-hours Primary Care: the CHILI Cluster Randomised Trial |
| Study Start Date : | November 2015 |
| Actual Primary Completion Date : | June 2016 |
| Actual Study Completion Date : | June 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention
All GPs working at the participating GP out-of-hours centres that are in the intervention group will use the GP-parent information-exchange tool (interactive booklet).
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Behavioral: GP-parent information-exchange tool
The booklet incorporates already existing information about fever, alarm symptoms, advices use of medication and specific infectious diseases that frequently occur in childhood in combination with fever such as upper respiratory tract infections, and otitis media. The difference with these existing sources of information is the fact that they until now, were not incorporated into one booklet which can be physically handed over to parents.
Other Name: Interactive booklet |
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No Intervention: Control
All GPs working at the participating GP out-of-hours centres that are in the control group will provide care as usual.
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- Antibiotic Prescription [ Time Frame: Baseline (Initial consultation) ]Antibiotic prescriptions for febrile children in GP out-of-hours centres during the initial consultation (dichotomous scale; number of participants with an antibiotic prescription).
- Intention to re-consult [ Time Frame: Asked within two weeks after initial consultation ]Intention to re-consult for similar illnesses among parents, number of parents with the intention to re-consult
- Parental satisfaction with care [ Time Frame: Asked within two weeks after initial consultation ]VAS scale 1-10
- Self-reported adverse events related to the fever episode like hospital admission [ Time Frame: Asked within two weeks after initial consultation ]
- Antibiotic prescription rates at re-consultations [ Time Frame: Asked within two weeks after initial consultation ]Prescription rates at re-consultations for the same illness episode (defined as a consultation for the same reason over the last two weeks)
- Consultation rates [ Time Frame: During complete study period, during 6 months of study completion ]Consultation rates of fever related consultations of children below the age of 12 years between intervention and control groups, through 6 months of study completion.
- Referral to secondary care [ Time Frame: Baseline (during initial consultation) ]Number of participants with Referral to secondary care during initial consultation
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| Ages Eligible for Study: | 3 Months to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between three months and twelve years
- GP decides this is a fever-related consultation
Exclusion Criteria:
- Age under 3 months or over 12 years
- GP decides this is NOT a fever-related consultation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594553
| Netherlands | |
| Maastricht University | |
| Maastricht, Limburg, Netherlands, 6229 HA | |
| Principal Investigator: | Eefje de Bont, MD, MSc | Research Institute CAPHRI, Department of Family Medicine, Maastricht University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT02594553 |
| Other Study ID Numbers: |
ZonMw GGG - 836021022 |
| First Posted: | November 3, 2015 Key Record Dates |
| Last Update Posted: | September 16, 2016 |
| Last Verified: | October 2015 |
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Antibiotics Children General Practitioner GP After-hours care |
Out-of-hours care Booklet Primary Health Care Child |
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Hyperthermia Fever Body Temperature Changes Heat Stress Disorders Wounds and Injuries |